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infLuence Of anovulaTion and menopaUSe on the course of MS

Organizational Data

DRKS-ID:
DRKS00031183
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2023-02-16
Last update in DRKS:
2023-05-05
Registration type:
Prospective

Acronym/abbreviation of the study

LOTUS-MS

URL of the study

https://www.msregister.de/forschung/lotusms/

Brief summary in lay language

No Entry

Brief summary in scientific language

This non-interventional study collects data from female MS patients who are at least 18 years old and participate in the DMSG MS registry. The study investigates the association of total ovulatory years and total oestrogen exposure with disease progression (measured by EDSS) and coginitive performance (measured by SDMT). The data will be collected using questionnaires in the MS registry of the German Multiple Sclerosis Society (DMSG).

Health condition or problem studied

ICD10:
G35 - Multiple sclerosis
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Patients with an MS diagnosis who participate in the Multiple Sclerosis Register of the DMSG. These patients are interviewed once using a questionnaire on total oestrogen exposure and tested for cognition using the SDMT. In addition, patient data on demographics, course of disease and treatments, degree of disability (EDSS) and physical examination findings are taken from the patient file.

Endpoints

Primary outcome:
The primary endpoint is the time to reach an EDSS score of 4. This score is collected as part of the patients' clinical routines.
Secondary outcome:
A secondary endpoint is the time to reach an EDSS of 3 and 6. These values are collected as part of the patients' clinical routines. Another secondary endpoint is time to transition to SPMS and patient performance in SDMT.

Study Design

Purpose:
Basic research/physiological study
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
Cross-sectional study
Study type non-interventional:
Patient Registry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Universitätsklinikum der Ruhr-Universität Bochum
  • Medical center St.-Marien-Hospital GmbH Lünen
  • Medical center Jüdisches Krankenhaus Berlin
  • Medical center Knappschaftskrankenhaus Sulzbach
  • Doctor's practice Bamberg

Recruitment period and number of participants

Planned study start date:
2023-05-01
Actual study start date:
2023-05-02
Planned study completion date:
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Actual Study Completion Date:
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Target Sample Size:
1000
Final Sample Size:
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Inclusion Criteria

Sex:
Female
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
- Written informed consent for participation in the German Multiple Sclerosis Registry. - Definite MS with determinable course or HIS - Primary residence in Germany - Written informed consent for participation in this study

Exclusion Criteria

- MS course not determinable - Lack of capacity to consent

Addresses

Primary Sponsor

Klinik für Neurologie, Universitätsklinikum der Ruhr-Universität Bochum
44791 Bochum
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Neurologie, Universitätsklinikum der Ruhr-Universität Bochum, St. Josef-Hospital
Prof. Dr. med. Simon Faissner
Gudrunstraße 56
44791 Bochum
Germany
Telephone:
+49234 509 6443
Fax:
No Entry
Contact per E-Mail
URL:
https://www.klinikum-bochum.de/fachbereiche/neurologie/zentren-labore/forschungszentrum-neuroimmunologisches.html

Contact for Public Queries

Klinik für Neurologie, Universitätsklinikum der Ruhr-Universität Bochum, St. Josef-Hospital
Prof. Dr. med. Kerstin Hellwig
Gudrunstr. 56
44791 Bochum
Germany
Telephone:
+49234 509 6443
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Neurologie, Universitätsklinikum der Ruhr-Universität Bochum, St. Josef-Hospital
Prof. Dr. med. Kerstin Hellwig
Gudrunstr. 56
44791 Bochum
Germany
Telephone:
+49234 509 6443
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Other contact for scientific queries

MS Forschungs- und Projektentwicklungs-gGmbH
Krausenstr. 50
30171 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.msregister.de/

Sources of Monetary or Material Support

Private sponsorship (foundations, study societies, etc.)

Deutsche Multiple Sklerose Gesellschaft, Bundesverband e.V.
Krausenstr. 50
30171 Hannover
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
https://www.dmsg.de/

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Medizinischen Fakultät der Ruhr-Universität Bochum
Gesundheitscampus 33
44801 Bochum
Germany
Telephone:
+49-234-79816555
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-09-06
Ethics committee number:
22-7654
Vote of the Ethics Committee:
Approved
Date of the vote:
2023-01-11

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
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Related DRKS studies:
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Publication of study results

Planned publication:
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Publikationen/Studienergebnisse:
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Date of first publication of study results:
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DRKS entry published for the first time with results:
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Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry